Pharmaceutical

Laboratory-as-a-Service expert SmartLabs chooses Boston location

The cGMP design & build expert has chosen the new Drexel and Gattuso's Life Science Research Lab Facility for its first facility in the city

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Study finds $1 per reaction LAMP assay works for BCC testing

The novel assay has been assessed for detecting the bacteria responsible for many pharmaceutical product recalls, Burkholderia cepacia complex

Laboratory-as-a-Service expert SmartLabs chooses Boston location

The cGMP design & build expert has chosen the new Drexel and Gattuso's Life Science Research Lab Facility for its first facility in the city

CorMedix sees NDA approval delay due to CMO and API supplier issue

A Complete Response Letter (CRL) was received from the FDA stating that the DefenCath NDA cannot be approved until deficiencies recently conveyed t...

What are your pain points moving to Pharma 4.0?

Pharma 4.0 is an initiative created by the International Society for Pharmaceutical Engineering (ISPE) that aims to bring about a digital evolution...

QleanAir signs two Letters of Intent for large cleanroom projects

The two projects cover a cGMP cell therapy cleanroom and a USP 797 and USP 800 compliant cleanroom

Mycenax grants Exyte prestigious award after GMP project in Taiwan

Mycenax Biotech has granted Exyte its "2022 Excellent Award” after building its GMP facilty with augmented mammalian cell and fill/finish

Meeting large-scale HPAPI production needs

A recent expansion at Olon’s Rodano site will enable the company to produce highly potent APIs in large-scale product batches ranging from 30-150 kg

Regulatory warning letters in pharma: What can we learn post-COVID?

A look at how the COVID-19 pandemic impacted FDA inspections and the trends that have now cropped up reflecting industry changes. Mirna Vazquez and...

ILC Dover launches multi-compendial Water for Injection

The US-based company has launched a WFI offering for the biotech and regenerative therapy markets

ZETA Group finishes blood plasma EPCM project

Octapharma chose ZETA as the general planner for all essential planning phases and the coordination of the trades involved, which included structur...

Understanding cleanroom behaviours in compounding pharmacies

Protecting patients from poor-quality compounded drugs is a fundamental part of the US Food and Drug Administration’s (FDA) drug compounding progra...

A look at the US cleanroom market | Beyond the engineering

The infection control sector is intrinsically intertwined with the engineering sector, and any major change in demand and needs causes a domino eff...

WHO recognises MRC Cleanroom facility in Egypt

Egypt-based Biogeneric Pharma's cleanroom facility, built by MRC Cleanrooms, is being recognised as a tech transfer recipient by the World Health O...

A guide to dust control in the pharmaceutical sector

The dangers of dust in any workplace environment are well documented. From a business point of view, dust can impact productivity and product quali...